Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00301808|
Recruitment Status : Completed
First Posted : March 13, 2006
Results First Posted : May 13, 2014
Last Update Posted : December 14, 2017
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one chemotherapy drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium together with radiation therapy followed by docetaxel works in treating patients with stage III non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Cisplatin Drug: Docetaxel Drug: Pemetrexed disodium Radiation: Radiation therapy||Phase 2|
- Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by consolidation therapy with docetaxel.
- Assess the progression-free survival and overall survival.
- Assess the toxicity of this regimen.
OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7. Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for 3 courses.
After completion of study therapy, patients are followed at 1 month and periodically thereafter.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer)|
|Study Start Date :||November 2005|
|Primary Completion Date :||September 2012|
|Study Completion Date :||October 2012|
Experimental: Cisplatin, Docetaxel & Radiation Therapy
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Other Names:Drug: Docetaxel
Docetaxel 75 mg/m2 on day 1 of each cycle
Other Name: Taxotere®Drug: Pemetrexed disodium
Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Other Name: AlimtaRadiation: Radiation therapy
Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
- Probability of Overall Survival at One Year [ Time Frame: at 1 year ]Overall Survival at one year using Kaplan-Meier product-limit analysis
- Progression-free Survival [ Time Frame: Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later. ]Progression-free survival using Kaplan-Meier estimates
- Overall Survival [ Time Frame: Date of registration to the date of death ]Overall survival using Kaplan-Meier estimates
- Toxicity [ Time Frame: 72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year ]Toxicity: total number of SAEs and other AEs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301808
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Veterans Affairs Medical Center - Detroit|
|Detroit, Michigan, United States, 48201|
|Study Chair:||Shirish M. Gadgeel, MD||Barbara Ann Karmanos Cancer Institute|